The following data is part of a premarket notification filed by Future Impex Corp. with the FDA for Photic-100 Spectrophotometer.
Device ID | K854679 |
510k Number | K854679 |
Device Name: | PHOTIC-100 SPECTROPHOTOMETER |
Classification | Colorimeter, Photometer, Spectrophotometer For Clinical Use |
Applicant | FUTURE IMPEX CORP. 2076 DEER PARK AVE. Deerpark, NY 11729 |
Contact | Morad Dayoudzadeh |
Correspondent | Morad Dayoudzadeh FUTURE IMPEX CORP. 2076 DEER PARK AVE. Deerpark, NY 11729 |
Product Code | JJQ |
CFR Regulation Number | 862.2300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-11-20 |
Decision Date | 1986-02-20 |